Predictive Vascular System for Early Drug Development

This grant was awarded by the National Heart, Lung, and Blood Institute of the NIH in August 2011. This Phase II SBIR grant will support the creation of an extensive database of drug-induced vascular response in HemoShear's proprietary human surrogate vascular system. HemoShear will perform whole genome analysis and profile the effects of 50 known drugs as multiple bioavailable concentrations upon the human vasculature. Combining its expertise in vascular biology and proprietary bioinformatics methods, HemoShear will develop a predictive vascular database that can be used to score new drug compounds for vascular effects and safety risk. Completion of this Phase II SBIR will provide pharmaceutical and biotechnology companies with a unique new tool to assess human vascular response and provide more informed and reliable decision-making for drug development.

Specific Aims

Aim 1: To generate a comprehensive endothelial cell/smooth muscle cell (EC/SMC) genomic database in the HemoShear vascular inflammation system in response to known drug compounds that have the following effects on the vasculature: 1) direct/intended effect, 2) positive pleiotropic effect and 3) negative pleiotropic effect.

Aim 2: To establish a predictive vascular computational model using a strategic bioinformatics approach that will create common genome signatures across multiple classes of drugs.

Status Update: HemoShear is in the process of establishing External Program Scientific and Pharmaceutical Industry Advisory Boards which will advise HemoShear during the conduct of this research.

External Program Scientific Advisory Board: The purposes of this advisory board will be to provide objective oversight of study design, conduct and data management. Members will be recruited from bioinformatics, drug-industry advisory groups, and from former pharmaceutical industry executives with experience in drug discovery and safety.

External Pharmaceutical Industry Advisory Board: The purpose of this board will be to provide advice and expertise on specific drug/drug classes included in the study. Members are active pharmaceutical scientists in drug discovery, safety and bioinformatics.